The Evolution of HTA in Emerging Markets Health-Care ... - TREE

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OHE Consulting Report for PhRMA 5 January 2011 Resources are transferred from the federal government to states and municipalities to account for dental and medical care, ambulatory and hospital care, diagnostic exams, treatment surgeries and procedures, and for the Service of Ambulances (SAMU) and Transplants. III. Health Vigilance Focused on actions for epidemiological vigilance, devoted to vigilance, prevention and control of diseases, also including vaccination campaigns; and sanitary vigilance. IV. Pharmaceutical assistance The pharmaceutical assistance budget allocation will be detailed below. V. Management of SUS Focused on strengthening the Unified Health System, costing actions specific to the organization and broadening of access to health services. Pharmaceutical Spending The pharmaceutical assistance is segmented into three components. Basic Component of Pharmaceutical Assistance Devoted to the acquisition of medications related to basic health attention. Its financing is composed by a fixed budget transfer from the federal government to states and municipalities, which must use the budget allocated to basic pharmaceutical assistance. To define which drugs will be provided by states and municipalities, the federal government defines a National List of Essential Medicines (RENAME), which constitutes a recommendation for which drugs should be provided, but the exact list provided by each state is defined by their own State List of Essential Medicines, which may vary from state to state depending on local needs. The same happens for municipalities and each municipality creates its own Municipal List of Essential Medicines to be distributed to the population. The purchase of drugs from these programs may be made at the federal level or decentralized to states and municipalities. In this component there is a variable financing budget devoted to the acquisition of drugs for the programs of hypertension and diabetes, asthma, mental health, women health, nutrition support, and smoking cessation. Component of Strategic Pharmaceutical Assistance Dedicated to financing drugs for the programs of: -‐ -‐ Control of endemics, such as tuberculosis, leprosy, malaria, leishmaniasis, Barber bug fever, and other endemic diseases in regional or national level; Drugs to treat HIV/AIDS; 72
OHE Consulting Report for PhRMA 5 January 2011 -‐ Blood and blood products and immunobiologics. Component of Specialized Pharmaceutical Assistance This component is devoted to financing drugs on a list of specialized drugs. These are defined as drugs with potential of having a high budget impact, either due to treating high prevalent diseases or because of a high unit cost. The inclusion of new drugs in the list of this component should be evaluated by the National Commission for Technology Incorporation (CITEC), and all new inclusions should be accompanied by a clinical protocol and therapeutic guideline. In this list, there are three categories: 1A – Drugs purchased centralized by the federal government; 1B – Drugs purchased by states with funds from the federal government; 2 – Drugs purchased by states with their own funds; 3 – Drugs purchased by municipalities with their own funds. The drugs included in the three programs above are offered free of charge to patients. In addition to this, the Popular Pharmacy Program was created in 2004. This program is implemented in two ways: Pharmacies are owned by the State and managed by Oswaldo Cruz Foundation (FIOCRUZ). There are currently 521 pharmacies offering access to 107 drugs at cost. These drugs cover diseases with high incidence in Brazil –gastric ulcers, depression, asthma, infections, migraine, burns, alcoholism, among others. FIOCRUZ buys the drugs preferably from official public pharmaceutical laboratories and, whenever necessary, from private laboratories. Private pharmacies in a partnership with the public system: 7,292 pharmacies are eligible to offer drugs included in the program, covering treatments for diabetes, hypertension and contraceptives. The federal government pays for 80% of the reference list price and the difference should be paid by patients out-‐of-‐pocket. This is part of the initiative to universalize access to health care. The legal right to access to drugs for health Given constitutional right to health, Brazilian citizens sometimes sue the government for access to specific medicines that are not on the national formulary. The suit applies only to the specific patient who brings it: it is not a “class action.” Some would argue that this is an untenable approach in the long run. Effectively, it becomes a route around HTA as well as the negative decisions by CITEC). Clearly, it is a costly and inefficient method to reach these societal decisions. Provision and Reimbursement Services are provided by primary care units and public hospitals in the federal, state, and municipal level. Services may be also provided by private hospitals and clinics dedicated to the public system. 73
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The Evolution of HTA in Emerging Markets Health-Care ... - TREE

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